BR112013032841A8 - Method for producing powders for inhalation - Google Patents

Method for producing powders for inhalation

Info

Publication number
BR112013032841A8
BR112013032841A8 BR112013032841A BR112013032841A BR112013032841A8 BR 112013032841 A8 BR112013032841 A8 BR 112013032841A8 BR 112013032841 A BR112013032841 A BR 112013032841A BR 112013032841 A BR112013032841 A BR 112013032841A BR 112013032841 A8 BR112013032841 A8 BR 112013032841A8
Authority
BR
Brazil
Prior art keywords
inhalation
active ingredient
mixing
powders
producing powders
Prior art date
Application number
BR112013032841A
Other languages
Portuguese (pt)
Other versions
BR112013032841B1 (en
BR112013032841A2 (en
Inventor
Shinichi Ono
Original Assignee
Clinipro Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Clinipro Co Ltd filed Critical Clinipro Co Ltd
Publication of BR112013032841A2 publication Critical patent/BR112013032841A2/en
Publication of BR112013032841A8 publication Critical patent/BR112013032841A8/en
Publication of BR112013032841B1 publication Critical patent/BR112013032841B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Emergency Medicine (AREA)
  • Otolaryngology (AREA)
  • Biochemistry (AREA)
  • Pain & Pain Management (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

método para a produção de pós para inalação. [problemas] a presente invenção fornece um método para a produção de pós para inalação, em que o desvio é menor na distribuição e a capacidade de dispersão é excelente. [soluções] a presente invenção se refere a um método para a produção de pós para inalação, compreendendo: uma primeira etapa de mistura de agitação de um primeiro ingrediente ativo e um carreador na presença de um meio de moagem, e mistura do primeiro ingrediente ativo e do carreador ao desintegrar os 'aglomerados do primeiro ingrediente ativo para obter uma mistura do carreador e do primeiro ingrediente ativo; e uma segunda etapa de adição de pós finos para a mistura obtida na primeira etapa de mistura, e agitação e mistura da mistura e dos pós finos na presença de um meio de moagem.method for producing powders for inhalation. [Problems] The present invention provides a method for producing powders for inhalation, where the deviation is smaller in the distribution and the dispersibility is excellent. [solutions] The present invention relates to a method for producing powders for inhalation, comprising: a first step of stirring mixing a first active ingredient and a carrier in the presence of a milling medium, and mixing the first active ingredient and the carrier by disintegrating the agglomerates of the first active ingredient to obtain a mixture of the carrier and the first active ingredient; and a second step of adding fine powders to the mixture obtained in the first mixing step, and stirring and mixing the mixture and fine powders in the presence of a milling medium.

BR112013032841-0A 2012-06-13 2013-02-25 Method for producing powders for inhalation BR112013032841B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2012134171A JP5087182B1 (en) 2012-06-13 2012-06-13 Method for producing inhalable powder
JP2012-134171 2012-06-13
PCT/JP2013/054710 WO2013187088A1 (en) 2012-06-13 2013-02-25 Method for producing powder for inhalation

Publications (3)

Publication Number Publication Date
BR112013032841A2 BR112013032841A2 (en) 2017-02-21
BR112013032841A8 true BR112013032841A8 (en) 2021-09-08
BR112013032841B1 BR112013032841B1 (en) 2022-04-05

Family

ID=47435636

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013032841-0A BR112013032841B1 (en) 2012-06-13 2013-02-25 Method for producing powders for inhalation

Country Status (12)

Country Link
US (1) US9532958B2 (en)
EP (1) EP2716281B1 (en)
JP (1) JP5087182B1 (en)
CN (1) CN103619326B (en)
AU (1) AU2013275641B2 (en)
BR (1) BR112013032841B1 (en)
CA (1) CA2840372C (en)
IL (1) IL229834B (en)
NZ (1) NZ620714A (en)
PT (1) PT2716281T (en)
RU (1) RU2013154972A (en)
WO (1) WO2013187088A1 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5266335B2 (en) 2008-01-31 2013-08-21 エクソンモービル・ケミカル・パテンツ・インク Improved utilization of linear alpha olefins in the production of poly-alpha olefins over metallocene catalysts
JP6116206B2 (en) * 2012-11-26 2017-04-19 クリニプロ株式会社 Method for producing inhalable powder
CN108066329B (en) * 2016-11-11 2021-11-16 江苏恒瑞医药股份有限公司 Preparation method of microparticles of fluticasone or derivatives thereof for inhalation

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4140689B4 (en) * 1991-12-10 2007-11-22 Boehringer Ingelheim Kg Inhalable powders and process for their preparation
JP2001151673A (en) * 1999-09-06 2001-06-05 Nikken Chem Co Ltd Production of powdery preparation for inhalation
WO2001026630A1 (en) * 1999-10-12 2001-04-19 Kaken Pharmaceutical Co., Ltd. Powdery inhalational preparations and process for producing the same
GB0010709D0 (en) * 2000-05-03 2000-06-28 Vectura Ltd Powders for use a in dry powder inhaler
ATE424811T1 (en) 2000-08-31 2009-03-15 Jagotec Ag GROUND PARTICLES
CA2430318C (en) * 2000-11-29 2009-10-27 Itoham Foods Inc. Powder formulation and method for producing the same
ES2689704T3 (en) * 2000-11-30 2018-11-15 Vectura Limited Particles for use in a pharmaceutical composition
JP4744876B2 (en) 2002-08-21 2011-08-10 ノートン・ヘルスケアー リミテッド Method for producing a dry powder inhalation composition
US20050158248A1 (en) 2002-08-21 2005-07-21 Xian-Ming Zeng Method of preparing dry powder inhalation compositions
US7230012B2 (en) 2002-11-14 2007-06-12 Celgene Corporation Pharmaceutical compositions and dosage forms of thalidomide
JO3102B1 (en) * 2004-03-17 2017-09-20 Chiesi Framaceutici S P A Pharmaceutical formulations for dry powder inhalers comprising a low- dosage strength active ingredient
GB0525254D0 (en) * 2005-12-12 2006-01-18 Jagotec Ag Powder compositions for inhalation
EP1973523A2 (en) * 2005-12-15 2008-10-01 Acusphere, Inc. Processes for making particle-based pharmaceutical formulations for pulmonary or nasal administration
GB0714134D0 (en) 2007-07-19 2007-08-29 Norton Healthcare Ltd Dry-powder medicament
CN101422436B (en) * 2007-10-31 2010-12-01 江苏正大天晴药业股份有限公司 Dry powder composite for suction
US20110105449A1 (en) 2007-11-07 2011-05-05 Astrazeneca R&D Dry powder formulations comprising ascorbic acid derivates
JP2009279558A (en) 2008-05-26 2009-12-03 Sumitomo Wiring Syst Ltd Mixing device
EP2571486A4 (en) * 2010-05-20 2013-12-04 Sun Pharma Advanced Res Co Ltd Dry powder inhalation composition

Also Published As

Publication number Publication date
US20140134254A1 (en) 2014-05-15
CN103619326B (en) 2018-05-22
PT2716281T (en) 2020-11-19
IL229834A0 (en) 2014-03-31
RU2013154972A (en) 2015-06-20
BR112013032841B1 (en) 2022-04-05
EP2716281A4 (en) 2015-08-26
JP2013255708A (en) 2013-12-26
EP2716281A1 (en) 2014-04-09
CA2840372C (en) 2017-12-12
JP5087182B1 (en) 2012-11-28
BR112013032841A2 (en) 2017-02-21
CN103619326A (en) 2014-03-05
AU2013275641B2 (en) 2017-02-02
US9532958B2 (en) 2017-01-03
AU2013275641A1 (en) 2014-02-27
NZ620714A (en) 2017-01-27
IL229834B (en) 2019-12-31
EP2716281B1 (en) 2020-09-30
CA2840372A1 (en) 2013-12-19
WO2013187088A1 (en) 2013-12-19

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B15K Others concerning applications: alteration of classification

Free format text: AS CLASSIFICACOES ANTERIORES ERAM: A61K 9/14 , A61J 3/02 , A61K 9/72 , A61K 31/137 , A61K 31/569 , A61K 47/26 , A61P 11/00 , A61P 11/06 , A61P 11/08

Ipc: A61K 9/16 (2006.01), A61K 31/137 (2006.01), A61K 3

B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/02/2013, OBSERVADAS AS CONDICOES LEGAIS.